The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Curietron.
| Device ID | K840127 |
| 510k Number | K840127 |
| Device Name: | CURIETRON |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | SYNCOR INTL. CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-11 |
| Decision Date | 1984-03-19 |